Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07099365

Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App

Led by King's College London · Updated on 2025-09-16

60

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

A

Avegen Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a two-arm, randomised controlled cross-over feasibility study with a nested, optional qualitative study. The intervention consists of a self-guided smartphone app (Orbi) based on cognitive behavioural therapy (CBT) principles, which is designed to support psychological adjustment in long-term physical conditions. Orbi is an app adaption of an existing, evidence-based web-based intervention COMPASS. The control condition consists of usual charity support (UCS) for the relevant long-term physical health conditions (LTCs). All charity support includes a helpline which can be accessed via telephone or email. The goal of this trial is to evaluate the feasibility of Orbi and the main questions it aims to answer are: 1. Is Orbi a feasible and acceptable intervention for individuals experiencing psychological distress related to LTCs? 2. Which aspects of the Orbi app and the trial enhance or diminish participants' experiences? Participants will: * Be randomised and each participant has an equal (50 %) chance of being assigned either to the Orbi+UCS group or to UCS group alone for 12 weeks. After 12 weeks, they will be crossed over to the alternate condition for another 12 weeks * Complete questionnaires to assess psychological distress and intervention engagement at baseline, 6 weeks, and 12 weeks. * A subset of participants will be invited to take part in a nested, optional semi-structured interviews to explore their experiences using Orbi and participating in the study.

CONDITIONS

Official Title

Psychological Adjustment to Long-term (PAL) Physical Conditions: A Randomised Cross-over Feasibility Trial of a Self-guided App

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Proficient in verbal and written English
  • Resident in the United Kingdom and registered with a General Practitioner
  • Have basic computer skills
  • Have an email address to register with Orbi
  • Have a long-term physical health condition
  • Experiencing distress related to their long-term physical condition
Not Eligible

You will not qualify if you...

  • Evidence of substance dependency, cognitive impairment, or severe mental health conditions as identified by usual care screening
  • Severe depression or anxiety indicated by scoring over 6 on the PHQ-4 questionnaire or scoring 1 or above on the PHQ-9 suicide risk question
  • Currently receiving active psychological treatment from a psychologist, counsellor, therapist, or online psychological intervention

AI-Screening

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Trial Site Locations

Total: 1 location

1

Health Psychology Department, King's College London

London, London, United Kingdom, SE1 9RT

Actively Recruiting

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Research Team

R

Rona Moss-Morris, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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